BRISBANE, AUS, Feb 5, 2026 - (ACN Newswire) - Annature, Australia's leading eSignature and Identity verification provider, has announced the release of its 21 CFR Part 11 compliant electronic signature module, enabling organisations operating in FDA‑regulated environments to execute electronic records with confidence.
The new capability ensures Annature customers can meet the U.S. Food and Drug Administration's requirements for electronic records and electronic signatures under 21 CFR Part 11, a regulation that governs data integrity, signer authentication, and auditability across industries such as life sciences, pharmaceuticals, biotechnology, and clinical research.
The release has been driven by growing demand from U.S.-based and multinational organisations seeking a modern, compliant alternative to legacy eSignature platforms. Several customers operating in regulated environments have already transitioned to Annature as part of broader digital transformation initiatives, prompting the company to formally introduce Part 11 support as part of its international product roadmap.
"As we continue to grow globally, it's critical that Annature supports the regulatory frameworks our customers operate under," said Corey Cacic, CEO of Annature. "Our 21 CFR Part 11 module allows organisations subject to FDA requirements to use Annature with confidence, knowing their electronic signatures meet the necessary compliance standards."
The module introduces controls aligned with Part 11 expectations, including secure signer authentication, tamper‑evident audit trails, and strong linkage between electronic signatures and the records they relate to. These features ensure electronic signatures executed through Annature can be relied upon in regulated workflows and during regulatory review.
Kim Steel, Founder and Managing Director of SAPRO - a boutique CRO supporting niche biotech and pharmaceutical companies with commercially sponsored Phase I-III full-service clinical trials has welcomed the release.
"For organisations operating in regulated environments, compliance with 21 CFR Part 11 is not optional - it is fundamental," said Steel. "It is encouraging to see Annature, an Australian technology provider supporting international regulatory requirements that are critical to our industry and our clients. Solutions like this enable sponsors to operate confidently on a global stage, without reliance on outdated or overly complex legacy systems, while remaining inspection and audit-ready at all times."
The launch further strengthens Annature's position as a global‑ready eSignature platform, supporting organisations that operate across jurisdictions with varying compliance obligations. The 21 CFR Part 11 module is available now and can be enabled for customers who require FDA‑compliant electronic signatures.
About Annature
Annature is Australia's leading eSignature and Identity verification provider, trusted by over 6,700 businesses. With a Pay as you go model and deep integration across the business app ecosystem, Annature delivers secure, affordable, and locally supported solutions for professionals across the country. Annature's growing product suite also includes integrated payments and compliance features designed to support both domestic and international regulatory requirements.
CONTACT:
Name: Corey Cacic
Email: corey@annature.com.au
SOURCE: Annature
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